NDC 65841-699 Ramipril

Ramipril

NDC Product Code 65841-699

NDC CODE: 65841-699

Proprietary Name: Ramipril What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ramipril What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Ramipril is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Ramipril is also used to improve survival after a heart attack. It may also be used in high risk patients (such as patients with heart disease/diabetes) to help prevent heart attacks and strokes. This medication may also be used to treat heart failure in patients who have had a recent heart attack. Ramipril is an ACE inhibitor and works by relaxing blood vessels so that blood can flow more easily.

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOW)
Shape: CAPSULE (C48336)
Size(s):
8 MM
Imprint(s):
374
Score: 1

NDC Code Structure

NDC 65841-699-01

Package Description: 100 TABLET in 1 BOTTLE

NDC 65841-699-05

Package Description: 500 TABLET in 1 BOTTLE

NDC 65841-699-06

Package Description: 30 TABLET in 1 BOTTLE

NDC 65841-699-10

Package Description: 1000 TABLET in 1 BOTTLE

NDC 65841-699-16

Package Description: 90 TABLET in 1 BOTTLE

NDC 65841-699-77

Package Description: 10 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK

NDC Product Information

Ramipril with NDC 65841-699 is a a human prescription drug product labeled by Cadila Healthcare Limited. The generic name of Ramipril is ramipril. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 251856, 251857, 401965 and 401968.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ramipril Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Angiotensin Converting Enzyme Inhibitor - [EPC] (Established Pharmacologic Class)
  • Angiotensin-converting Enzyme Inhibitors - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cadila Healthcare Limited
Labeler Code: 65841
FDA Application Number: ANDA090697 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-05-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.